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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

94 01 000 — Class IIb MDD by A.T.S. Applicazione…

MD Atlas
A.T.S. Applicazione Tecnologie Speciali s.r.l.

EUDAMED last updated this device on May 26, 2023

94 01 000

B-08055186671065

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: A.T.S. Applicazione Tecnologie Speciali s.r.l.
UDI-DI code: 08055186671065
Reference / catalog number: 94 01 000

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View device family (Basic UDI)

Manufacturer information

Organization name: A.T.S. Applicazione Tecnologie Speciali s.r.l.
SRN: IT-MF-000010734
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	May 28, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08055186671065
Basic UDI-DI: B-08055186671065
Reference / catalog number: 94 01 000
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Portable radiological image acquisition and processing system with digital detector for radiography.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08055186671065

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z11031101MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Related devices

74 10 000-2; 74 12 000-2805518667FPVPOn the market 74 10 000-3; 74 12 000-3; 74 14 000; 74 15 000805518667FPVPOn the market 74 09 000-1 / 74 11 000-1B-08055186670457On the market 74 09 000-2 / 74 11 000-2B-08055186670464On the market 74 10 000-1 / 74 12 000-1B-08055186670471On the market

Certificates

Certificate health across this manufacturer's portfolio.

ITH 2492603 1Supplemented
Quality management systemNotified body: 1936Expiry: Dec 10, 2028